MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 9 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202272
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an acl procedure, the biosure screw surface was too small and could not fix the tendon.Broken pieces fell inside the patient and were retrieved with tweezers.The procedure was completed with a non-significant surgical delay using a back-up device in the originally drilled bone hole.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device did not contribute to the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.A review of the part drawing found that the dimensions and tolerances are appropriately specified.A review of the customer provided images found labelling confirming the product identification information.The proximal end of the screw is severely deformed and appears to be broken in several places.A visual inspection of the returned device found that it is not in its original packaging.The screw is severely deformed and flattened on the proximal end, and the threads are broken.There is debris on the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.A functional evaluation could not be performed due to the condition in which the device was received.A dimensional evaluation of the device could not be performed due to the severe deformation of the screw.Per case details the broken pieces were retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint of a break was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.The complaint of the device being too small and unable to fix the tendon was not confirmed, and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the reported event include inadequate bone quality, improper preparation of the insertion site, off-axis insertion of the device, or use of the wrong sized device for the prepared insertion site.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: BIOSURE PK 9 X 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13691518
• Report Number: 1219602-2022-00332
• Device Sequence Number: 16611781
• Product Code: MBI
• UDI-Device Identifier: 03596010621634
• UDI-Public: 03596010621634
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2026
• Device Model Number: 72202272
• Device Catalogue Number: 72202272
• Device Lot Number: 50947672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown